Body composition prediction tools

ABSTRACT

A system for calculating one or more health indicators, comprising a body volume calculator arranged to use measurement data to calculate the volume of at least a part of a subject&#39;s body and a length measurement of at least a part of a subject; and processing circuitry arranged to receive information, which may be demographic information, about the subject and the body part volume and length measurements; and to perform at least one of: calculating a predicted Visceral Fat value and/or a predicted Total Body Fat value from the demographic information, the body part volume and length measurements using first and second formulae, which may be empirical formulae, respectively; and calculating a Body Volume Indicator (BVI) arranged to provide an indication of health risk, in particular obesity and cardio-metabolic risk, which may be by using a third formula, which again may be an empirical formula.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. application Ser. No.16/608,642 filed Oct. 25, 2019, which is the U.S. national stage filingof PCT Application No. PCT/GB2018/051122 filed Apr. 27, 2018, whichclaims priority benefits of GB Application No. 1706857.8 filed Apr. 28,2017 and U.S. Provisional Application No. 62/491,764 filed Apr. 28,2017, the technical disclosures of which are hereby incorporated hereinby reference.

The invention relates to health risk prediction tools for use in healthmanagement, and in particular to a biomarker calculated using one ormore 3D body part volumes and/or length measurements of a subject, whichmay be generated from a three-dimensional model of a person, howsoevercreated. More specifically, the invention relates to methods ofcalculating and using such a biomarker and to the prediction of“internal” (body composition) data from “external” data including one ormore 3D body part volumes and/or lengths. In particular, the biomarkeris or comprises a Body Volume Indicator (BVI®), which is calculatedusing one or more body part volume and/or length measurements of thesubject, and demographic information.

Indications of a person's health in the management of healthcare can beconfigured and represented in different ways; for example as a number,as a series of numbers, as a combination of letters and numbers, or insome cases as one or more symbols.

However, the relevance of that number or designated reference isnormally restricted to the medical condition or the type of risk thatmight be associated with that condition. These numbers or referencesthen become associated with and attributed both to the problem (i.e. thecondition that is being treated) and then subsequently used as abarometer or indicator of risk (to provide a healthcare professionalwith guidelines or project or surrogate risk (i.e. expected outcome asopposed to actual outcome of risk) relevant to the condition). This ismore commonly referred to as a barometer of risk or more colloquially asa ‘biomarker’. As an example of “surrogate risk”, a surrogate risk forcardiovascular disease is a designation that predicts likelihood ofsomeone having a heart attack. The actual outcome is whether or not thatperson ever does have a heart attack. A surrogate marker of risk isanticipated risk as a result of healthcare factors.

In terms of the biomarkers which are currently used, with referenceranges, in the measurement of the human body, the Body Mass Index (BMI)is currently the most common biomarker of risk for general human health.

First published in 1835 by Adolphe Quetelet, BMI relies on height andweight only to provide an indication of risk referenced against a scaleand this is now widely considered to be of value in populationstatistics only and not suitable for individual risk (for example due tothe inability to distinguish between muscle mass and fat mass anddifferent body types). BMI does not distinguish between subjects whohave different weight distributions and so have different risk profiles.

This application relates to a particular method suitable for use withthe invention described in granted European Patent EP1993443 (HealthIndicator) and the granted U.S. Pat. No. 8,374,671 (Health Indicator),which mention that an indication of a person's health can be given as afigure labelled BVI® (“Body Volume Indicator”), which may be calculatedusing the ratios between the various body part volumes discussedtherein.

The present invention builds upon the use of part-volumes of the body in3D as described in the previous patent.

In summary, the body volume system has undergone a confidentialvalidation and research program involving some of the world's mostprestigious and renowned scientific establishments. The inventiondisclosed herein concerns exemplary processes and procedures, andsummarises the data which have been consolidated to produce an inventivebiomarker of health risk; comparable in effect and scope to the BodyMass Index. The Body Volume Indicator (BVI®) is intended to become andbe recognised as a novel biomarker of risk, offering a unique usage ofpart volume, and therefore part body shape, to the scientific andhealthcare community.

According to a first aspect of the invention, there is provided a systemarranged to calculate one or more health indicators, comprising:

-   -   a body volume calculator arranged to use measurement data to        calculate the volume of at least a part of a subject's body and        a length measurement of at least a part of a subject's body;    -   processing circuitry arranged to:        -   (i) receive information, which may be demographic            information, about the subject and the body part volume and            length measurements;        -   and to perform at least one of:        -   (ii) calculating a predicted Visceral Fat value and/or a            predicted Total Body Fat value from the demographic            information, the body part volume and length measurements            using first and/or second formulae, which may be empirical            formulae, respectively; and        -   (iii) calculating a Body Volume Indicator (BVI®) arranged to            provide an indication of health risk, in particular obesity            and cardio-metabolic risk, which may be by using a third            formula, which again may be an empirical formula.

The processing circuitry may be provided by a processing unit, forexample an Intel® X86 processor such as an 15, 17 processor or the like.The skilled person will appreciate that any suitable processor or thelikes known in the art may be used.

Optionally, the BVI® is a single number, which may have one or moredigits, optionally including one or more decimal places.

Optionally, one or more body surface area measurements may also be used,for example when assessing risks relative to burn area for burnspatients.

According to a second aspect of the invention, there is provided amethod of calculating a Body Volume Indicator (BVI®), comprisinginputting at least one item of demographic information, at least onebody part volume measurement and at least one body length measurement ofa subject into an empirical formula for BVI®, the empirical formulabeing determined from a database comprising corresponding demographicinformation, body part volume and length information and internal bodycomposition data for a plurality of individuals. Optionally, differentdatabases, or different sections within a database, may be used fordifferent demographic groups of individuals.

Optionally, the internal body composition data are obtained using MRIscans. Optionally, the MRI scans have been processed to obtain TotalBody Fat and Visceral Fat data, those data being provided as at leastpart of the internal body composition data.

Optionally, the internal body composition data and part volumes for thedatabase may be obtained using empirical cadaver data and MRI scans.

Optionally, the at least one item of demographic information for theBVI® formula comprises at least one of age, ethnicity and gender.

Optionally, the at least one body part volume measurement for the BVI®formula comprises abdominal volume.

Optionally, the at least one body length measurement for the BVI®formula comprises at least one of height and waist girth.

Optionally, one or more body surface area measurements may also be used,for example when assessing risks relative to burn area for burnspatients.

According to a third aspect of the invention, there is provided a methodof calculating a predicted Total Body Fat or Visceral Fat value,comprising inputting at least one item of demographic information, andat least one body length measurement of a subject into an empiricalformula for Total Body Fat or Visceral Fat (respectively), the empiricalformula being determined from a database comprising correspondingdemographic information, body part volume and length information andinternal body composition data for a plurality of individuals.

Optionally, at least one body part volume measurement is also input.

Optionally, the at least one item of demographic information for theTotal Body Fat or Visceral Fat formula comprises at least one of age,ethnicity, and gender.

Optionally, the at least one body length measurement for the Total BodyFat or Visceral Fat formula comprises at least one of height, hip girthand waist girth. Optionally, age and/or gender may also be included.

Optionally, weight is input.

Optionally, a measure of activity level is input.

According to a fourth aspect of the invention, there is provided adiagnostic tool comprising a Body Volume Indicator determined accordingto the second aspect of the invention.

Optionally, the diagnostic tool further comprises a predicted VisceralFat value calculated from external measurements and demographicinformation.

Optionally, the diagnostic tool further comprises a predicted Total BodyFat value calculated from external measurements and demographicinformation.

According to a fifth aspect of the invention, there is provided amachine readable medium containing instructions which, when read by amachine, causes that machine to perform the method of the second aspectof the invention.

According to a sixth aspect of the invention, there is provided anindication of health and fitness comprising:

-   -   3D photonic and MRI data;    -   a single digit or double-digit whole number;    -   a decimal place after the single-digit or double-digit number;    -   a series of ranges against which the single-digit number or        double-digit number is referenced;    -   volumetric measurements of the human body;    -   linear measurements of the human body;    -   body composition measurements of the human body;    -   social information about a human being or beings;    -   demographic information about a human being or beings;    -   physical attributes about a human being or beings;    -   fitness and activity information about a human being or beings;    -   dietary information about a human being or beings;    -   medical information about a human being or beings;    -   reference information about a human being or beings;    -   BVI® designation about a human being or beings;    -   body database comprising all of the above wherein    -   said single-digit number or double-digit number is configured to        provide an indication of the health risk or fitness of a person    -   said single-digit number or double-digit number is configured to        provide an indication of the scale of the health risk or fitness        of a person, by reference to a series of ranges    -   said single digit number or double-digit number is configured to        provide an indication of the health or fitness of said person by        retrieving data from the said body database and using a ratio of        the said body database information of a new person, then        calculating a said indication of health risk to the said        database of known persons.

Optionally the single and double digit numbers are arranged to providethe indication of health risk by reference to a designated series ofranges between one single-digit and another single-digit number, betweena single-digit and a double-digit number or between a double-digitnumber and another double-digit number

Optionally the volumetric measurements include but are not limited tothe volume of the pelvis, abdomen, chest, right arm, left arm, rightleg, left leg and neck.

Optionally the linear measurements include but are not limited to waist,hip, chest, thigh girth, neck girth, bicep girth and leg length.

Optionally, the body composition measurements include but are notlimited to body fat, visceral fat, muscle, adipose tissue, liver fat,fat free mass, subcutaneous fat and bone.

Optionally, the social information include but are not limited to homelocation, marital status, employment, background and lifestyle.

Optionally the demographic information include but are not limited toage, gender, ethnicity and socio-economic grouping.

Optionally the physical attributes are to include but are not limited tophysical height and weight.

Optionally the fitness and activity information include but are notlimited to number of steps taken, frequency of exercise, level ofphysical activity and attitudes to fitness and activity.

Optionally the dietary information include but are not limited to typeof food eaten, volume of food eaten, time of day eaten, types of dietsundertaken and attitudes to food.

Optionally the medical information include but are not limited toprevious medical history, medical conditions recorded, blood testresults and genetic pre-conditions and risk elements.

Optionally the reference information includes but is not limited to aPatient ID number, a Client ID Number, an NHS Reference Number (orequivalent for other health service providers or registers) and a UniqueIdentifying number, letter or other designation used as a reference.

Optionally the body database includes some or all of the information andmeasurements described above. The data may be stored and trends trackedfor subject and population purposes.

Optionally the BVI® designation includes but is not limited to one orall of the information and measurements described above.

Optionally the indication includes, but is not limited to, a numberbelow or above the number 13.0.

Optionally the ranges include but are not limited to the ranges 0-4.9,5.0-9.9, 10.0-14.9, and 15.0-20.0.

Optionally the health risk includes but is not limited to Diabetes, HighBlood Pressure, Liver Disease, Cancer, Obesity and Improved Healthand/or Fitness.

Optionally, comparison information with average or aggregated data ofpeople with similar measurements may be shown.

Optionally, a comparison between any previous indication of a person'shealth and a present indication of that person's health may be shown.

According to a seventh aspect of the invention, there is provided anindication of health and fitness comprising;

-   -   a body database comprising at least some, and in some cases all,        of the information and measurements described with respect to        the sixth aspect,    -   said single-digit number or double-digit number is configured to        obtain an indication of the health risk or fitness of a person;    -   said single-digit number or double-digit number is configured to        calculate an indication of the scale of the health risk or        fitness of a person, by reference to a series of ranges;    -   said single digit number or double-digit number is configured to        provide an indication of the health or fitness of said person by        retrieving data from the said body database and using a ratio of        the said body database information of a new person, then        calculating a said indication of health risk to the said        database of known persons.

Optionally, the body database is used to collect aggregated datastatistics, which may be stored in a separate database.

According to an eighth aspect of the invention, there is provided amachine readable medium containing instructions which when read by amachine causes that machine to perform as the indication of health andfitness of the fourth aspect.

According to a ninth aspect of the invention, there is provided amachine readable medium containing instructions which when read by amachine causes that machine to perform as the indication of health andfitness of the fifth aspect.

The skilled person would understand that features described with respectto one aspect of the invention may be applied, mutatis mutandis, to theother aspect of the invention.

Reference to a machine readable medium herein, may refer to a transitoryor non-transitory media, and will include, but not be limited to any ofthe following: a floppy disc, a DVD, a CD ROM or RAM, a memory (such asa Flash drive, an SD card, a solid state memory, etc.), a hard drive, acoding process deployed and used on a cloud server, a download (such andInternet download, FTP transfer or the like), a wire, or the like.

The skilled person will appreciate that many features described above inrelation to any of the aspects could be provided by software, firmwareor hardware and moreover the skilled person will understand theequivalence of the software, firmware and hardware.

There now follows by way of example only a detailed description ofembodiments of the present invention with reference to the accompanyingdrawings in which:

FIG. 1 shows a diagrammatic representation of a health indicator devicesuitable for calculating BVI® and optionally for use in determining anappropriate formula for the calculation of BVI®;

FIG. 2 shows an example of a BVI® datasheet;

FIG. 3 shows a flow chart of a first method of determining empiricalformulae to output the desired values;

FIG. 4 shows a flow chart of use of the empirical formulae in providinga diagnostic tool;

FIG. 5 shows a summary of the processes shown in FIGS. 3 and 4; and

FIG. 6 shows a diagrammatic representation of a health indicator devicesuitable for calculating BVI® and optionally for use in determining anappropriate formula for the calculation of BVI®.

The embodiments described herein relate to a health indicator that canbe used in the assessment of a person's (e.g. a patient's) health. Theindicator disclosed can also be used as a weight management tool asdescribed below.

It is believed that the health indicator will be used by medicalprofessionals, Dieticians and Nutritionists to monitor weight loss orweight gain in patients, but it may also be used personally. The healthindicator may even be used by slimming clubs or for assessment of healthinsurance premiums, as an alternative to simply being weighed and theperson's BMI being calculated manually using just height and weight.

In FIG. 1, a device 1 suitable for calculating the health indicator (a“health indicator device”) is shown comprising a body scanner 2, datacollection means 3 and manipulation means 4. In the embodiment beingdescribed, the manipulation means 4 has a connection 5 to the Internet 6so that it can communicate with database means 7. It will be appreciatedthat the connection need not be via the Internet 6 and may be over aLocal Area Network, a direct connection or over a telephone linedepending upon the location of the manipulation means 4 and the databasemeans 7. The database means 7 also has access means 8 to enable it to beaccessed remotely by healthcare professionals 9 such as generalpractitioner (GP). The skilled person will appreciate that any otherhealth or fitness professional or the likes may take the place of a GPin alternative or additional examples, for example a Nurse, PhysicalTherapist, Consultant, Physician, Wellness or Fitness specialist. Inthis embodiment, the healthcare professional 9 can access the databasemeans 7 via the access means 8 over the Internet via a web-basedinterface.

The connection 5, 6 between the manipulation means 4 and the databasemeans 7 comprises a secure file transfer protocol connection, althoughany appropriate connection, secure or otherwise, could be used. Theconnection between the health professional 9 and the database means 7 isalso a secure connection, using known secure Internet transfer methodssuch as SSL (Secure Socket Layer).

The body scanner 2 in one embodiment comprises a NX₁₆ white lightscanner manufactured by TC². The scanner uses a plurality of white lightsources to illuminate the person's body such that sensors can obtainmeasurements of the size and shape of the person for the generation of athree-dimensional model.

The body scanner 2 in another embodiment comprises a self-containedstatic laser, white-light or photonic 3D body scanner. The scanner usesa plurality of Image and Sensor sources to record the person's body suchthat sensors can obtain measurements of the size and shape of the personfor the generation of a three-dimensional model.

Embodiments of the invention may take a pre-generated three-dimensionalmodel of a person, generated by any suitable body scanner 2. The 3Dmodel is used for the purposes of measuring part-volumes for thecreation of a biomarker.

In alternative or additional embodiments, two or more photonic images(for example a front-view photograph and a side-view photograph, whichmay be taken using a hand-held mobile device or tablet 60) may be usedto generate a 3D model of the subject for estimation part volumesinstead of a more traditional body scanner 2.

In alternative or additional embodiments, multiple girth and lengthmeasurements may be combined to provide estimates of part volumes,instead of or as well as a camera, 3D scanner 2 or the likes.

The device 1 comprises processing circuitry arranged to perform thevarious processing steps. The manipulation means 4 and the body scanner2 may each comprise some processing circuitry of the device 1.

In embodiments using measurements and/or images in place of a 3D scan,the processing to convert these data into a 3D model so as to extractvolume information can be thought of as a 3D scanner. This may beperformed, for example, online using software within a cloud-basedsystem available to multiple users. Circuitry which performs theprocessing may be described as processing circuitry, whether or not itis a dedicated processing unit. The processing, and so the processingcircuitry, may be distributed. The cloud software may be thought of asthe “scanner” in such embodiments, as it effectively produces a 3D scanin a self-contained software environment.

The data collection means 3 comprises software loaded onto a computerthat is connected to the scanner 2. The manipulation means 4 alsocomprises software loaded on to the same computer, wherein themanipulation software receives its input from the output of the scannersoftware 3. The manipulation software 4 includes a body volumecalculator 11 and a health calculating device 19, both embodied assoftware in the embodiment being described.

The manipulation means 4 passes the data from the data collection means3 to the body volume calculator 11 with any additional information, forexample relevant to the health or medical history of a subject, asappropriate. For example, the manipulation means may specify for whichbody parts the volume calculator 11 should be calculated. The outputfrom the body volume calculator 11 is passed to the health calculatingdevice 19.

In some embodiments, the device 19 calculates a ratio between the firstvolume, corresponding to the first body part output by the volumecalculator, and the second volume corresponding to the second body partoutput by the volume calculator. In alternative or additionalembodiments, other combinations may be used instead of or as well asratios, and/or one or more length measurements may be used incombination with one or more volume measurements in the generation ofthe biomarker.

The manipulation means 4 also receives input from body compositiondatabase means 51. The database means 51 contains information frommedical surveys, for example, on the composition of people of differentsizes, shapes, gender, ages and ethnicity. Thus, by comparing theinformation entered into the manipulations means 4 about the personbeing scanned and the measurements made from the three-dimensionalmodel, the manipulation means 4 can extract the typical body compositionfor that person from the database means 51. As such, internal bodycomposition data can be inferred for a subject for whom only externaldata has been provided, by comparison to other individuals in thedatabase means 51 for whom internal data were provided (e.g. by way ofMRI scans and/or cadaver data).

This information is used by the health calculating device 19, incombination with the ratio between the first and second volumes (orother combination of volumetric and length data) to generate theindication of a person's health, which may then be displayed. Theindication of a person's health obtained can be used by the healthprofessional to assess the person's health and the health risks to whichthey could potentially by prone. The healthcare professional can thenrecommend preventative measures, changes to diet, exercise ormedication, surgery, or the like, to improve the health of the personscanned. The health indicator can therefore be used as a diagnostictool, and/or optionally as a predictive health tool.

The manipulation means 4 also receives input from a feedback means 52 inthe embodiment being described. The feedback means receives informationentered by a healthcare professional, for example, about any healthproblems that have developed in the scanned person. Such information canbe used by the manipulation means to validate or improve the indicationof a person's health initially calculated by the health calculatingdevice 19. For example, if the indication of a person's health indicatesthat the person had a high risk of heart disease and subsequently thatperson developed heart disease, this information can be received by thefeedback means 52. The health calculating device 19 may then (forexample through predictive artificial intelligence or machine learning)alter an importance factor associated with the body volumes and/orlengths etc. it used to calculate the indication of a person's health,so that subsequent calculations of people with a similar size, shape orcomposition yield an indication of health that emphasises the healthrisk to a healthcare professional. The feedback means 52 thereforeprovides the device 1 with a means to validate and iteratively improvethe accuracy of the results the health indicator device 19 produces.

The connection 5 may also be used to update the manipulation software 4from a computer server (not shown) also connected to the Internet, orother network.

The manipulation means 4 is also connected to an output means 12, whichcomprises a printer in the embodiment being described. The printer 12 isarranged to print a datasheet 13, 50 showing at least the output fromthe manipulation means 4. In alternative or additional embodiments, theoutput means may distribute the datasheet and/or a BVI® valueelectronically, and/or present it electronically. In alternativeembodiments, the output may be entirely electronic, for example adisplay on a screen, and a printer may not be present. Further, in someembodiments the output may be ephemeral—e.g. by being made visuallyavailable to the subject electronically and then deleted.

Details of a scanning method are provided in EP1993443 and U.S. Pat. No.8,374,671; the skilled person is directed to these granted patents forfurther details. The contents of these patents are hereby incorporatedby reference and the skilled person is directed to read these texts atleast to understand an example of the generated outputs of part-volumesfrom a three-dimensional 3D scan.

FIG. 6 shows a device 1 suitable for calculating the health indicator (a“health indicator device”). The device 1 may also be referred to as asystem or network, as various components are physically separate,although able to communicate, in the embodiment shown. A smart phone,tablet or the likes 60 serves as a data collection means 3. In theembodiment being described, a subject takes two (or more) photographs ofhim or herself, using the smart phone 60.

In the embodiment shown in FIG. 6, the body scanner 2 and datamanipulation means 4 are both provided by a cloud computing service 2,4. The cloud computing service 2, 4 receives the photographs andgenerates a 3D body model from the photographs, thereby performing therole of a body scanner.

In the embodiment being described, the smartphone 60 is also used toinput a client identifier (e.g. a username), one or more lengthmeasurements (e.g. height) and some basic personal information (e.g.demographic data such as age, gender and/or ethnicity). The skilledperson will appreciate that relative measurements may suffice in someembodiments—in such cases, no length measurements or other data toprovide a scale for the photographs may be needed.

The client identifier, photographs, measurements and basic personalinformation are then sent 601 to a BVI® server 62, for example over theInternet. In alternative or additional embodiments, client information(e.g. demographic data, length measurements, and/or the likes) may beprovided from a client server 7 a instead of from the smartphone 60. Insuch embodiments, a client identifier (e.g. a username or uniquereference number) may be provided via the smartphone 60 andcorresponding data may be retrieved from the client server 7 a for use,and/or the user may be prompted to supply any missing information.

In the embodiment shown, the BVI® server 62 is in communication with theclient server 7 a, such that data may be sent to, and retrieved from,the client server 7 a. The client server 7 a may store one or more of:

-   -   Client login data;    -   Personal data;    -   Historical data;    -   Photographs (optional); and    -   Body Volume, length and/or area data.

In the embodiment shown, the BVI® server 62 sends 602 the clientidentifier and basic personal information, the photographs and extractedmeasurements, to the cloud computing service 2, 4. The cloud computingservice 2,4 then generates a 3D model from the photographs, extracts themeasurements needed to calculate at least one of total body fat,visceral fat, and BVI®, and optionally also calculates BMI.

In alternative embodiments, the BVI® server 62 may generate the 3D modeland extract one or more body part volumes, area measurements and/orlength measurements and send those measurements to the cloud computingservice, instead of leaving the 3D model creation to the cloud computingservice.

In the embodiment shown, the cloud computing service 2, 4 is Incommunication 603 with BVI® server storage 7 b. The BVI® server storage7 b comprises a database of anonymous body composition data (internaldata, e.g. generated from MRI scans and/or cadaver data) andcorresponding body shape data. The database optionally additionallycomprises image storage.

The skilled person will appreciate that the internal data was taken intoaccount when determining the formulae, and the coefficients of theformulae, to use for BVI®, visceral fat, and/or total body fat, andthat, once the formulae have been established, access to the BVI® serverstorage 7 b is not necessary. However, additional data may be added,and/or the formulae or coefficients thereof may be refined based onnewly supplied data. In alternative embodiments, the generated 3D bodymodel may be matched against the BVI® server storage 7 b database toprovide estimated internal data for the subject whose external data wasused to generate the 3D body model.

In alternative embodiments, the cloud computing service 2, 4 may not bein communication 603 with the BVI® server storage 7 b. The cloudcomputing service 2, 4 may receive the formulae (or the coefficients fora pre-programmed formula) to use from a different source, thoseformulae/coefficients having been determined using data in the BVI®server storage 7 b previously.

Values for at least one of BVI®, total body fat, and visceral fat arethen transmitted 604 back to the BVI® server 62 from the cloud computingservice 2, 4. A BMI value may also be transmitted.

The BVI® server 62 provides the data (BVI®, total body fat, and/orvisceral fat, and optionally BMI) as results to the subject, bytransmission 606 to the smartphone 60, 3. In the embodiment beingdescribed, the values are colour-coded to represent a risk level (e.g.green for healthy, amber for be aware, and red for take action), andprovided alongside recommended products, services, and/or actions.Optionally, feedback and user experience management content may also beprovided, and user feedback may be sent from the smartphone 60, 3 backto the BVI® server 62.

The values may be provided without modification or other context inother embodiments.

In alternative embodiments, the roles of the BVI® server 62 and thecloud computing service 2, 4 may be provided by a single entity, and/orthe BVI® server storage 7 b may not be present, or may be combined withthe client server 7 a.

In alternative embodiments, any other suitable electronic device ordevices may replace the smartphone 60, 3.

FIG. 2 shows an example of a datasheet 50 printed by the printer 12.This datasheet shows a representation of the three-dimensional model 55generated by the device 1. It also includes a plurality of measurements56, some of which are calculated by the body volume calculator 11. Inparticular, the volume of the neck, upper torso, lower torso, abdomen,left arm, right arm, legs and total body is shown as calculated from thethree-dimensional model obtained by scanning the person. The indicationof a person's health is given as a figure labelled “BVI”, which may becalculated using the ratios between the above-mentioned volumes.

The BVI® biomarker may be presented in the format of, or incorporatedas, an ICD-10 code (10th revision of the International StatisticalClassification of Diseases and Related Health Problems, a medicalclassification list by the World Health Organization) or CPT code(Current Procedural Terminology).

The BVI® biomarker may be displayed and/or stored in an ICD-10 or CPTcode format, or encoded in any other appropriate manner.

The BVI® biomarker may be displayed in many different ways, for exampleon a health insurance certificate (hard copy or electronic copy), aspart of client information for a client account with a health-relatedorganisation, or the likes. Similarly, BVI® data may be stored andpresented in internal records, such as those of a healthcare, healthrisk prevention, or health insurance firm.

In the embodiments being described, the BVI® is configured to provide anindication of the health risk or fitness of a person. Health risk maycomprise one or more of the person's risk of Diabetes, High BloodPressure, Liver Disease, Cancer, Obesity. Changes in a person's BVI® mayalso indicate improved health and/or fitness as compared to a previousrecord or assessment.

In the embodiments being described, the BVI® figure is a number. Theskilled person will appreciate that letters, symbols or alphanumericcodes could be used to represent the numerical output of a BVIcalculation (described below) in other embodiments.

In the embodiments being described, the BVI® figure is a single-digit ordouble-digit number, for example in the range of 0 to 99, and morepreferably in the range of 0 to 20. In the embodiments being described,the BVI® figure has a decimal place following the single-digit ordouble-digit number. The skilled person will appreciate that othernumbers and ranges may be used in other embodiments.

In the embodiments being described, the BVI® calculation uses volumetricmeasurements of a subject's body, including two or more of the volume(or at least a portion of any of the following volumes) of the pelvis,abdomen, chest, right arm, left arm, right leg, left leg and neck.

In various embodiments, in addition to part volumes (volumetricmeasurements of the human body), the BVI® calculation uses one or moreof the following metrics:

-   -   linear measurements of the human body;    -   surface area measurements of the human body;    -   body composition measurements of the human body (e.g. MRI data,        Cadaver data, DEXA (Dual-energy X-ray Absorptiometry) data, or        the likes giving a measurement of Visceral Fat and of Total Body        Fat);    -   social information about a human being or beings;    -   demographic information about a human being or beings;    -   physical attributes of a human being or beings;    -   fitness and activity information about a human being or beings;    -   dietary information about a human being or beings;    -   medical information about a human being or beings; and    -   reference information about a human being or beings.

The metrics listed above may be present in the data inputted by asubject and/or a healthcare professional, and/or in the constants usedwithin the empirical formula used to calculate BVI® for a subject, theconstants being calculated based on the above metrics extracted from thebody database. Advantageously, in some embodiments the subject only hasto enter external information such as height, weight, body part lengthsand volumes and demographic information, and does not have to obtainmeasures of internal information such as body composition measurements.The fusion of internal and external data in the database may allow theempirical formula determined using the database to implicitly takepredicted/expected internal information into account.

In the embodiments being described, the linear measurements comprise atleast one of height, waist circumference, hip circumference, chestcircumference, thigh girth, neck girth, bicep girth and leg length.

In the embodiments being described, the body composition measurementscomprise at least one of body fat, visceral fat, liver fat, muscle,adipose tissue, fat free mass, subcutaneous fat and bone.

In the embodiments being described, the social information comprises atleast one of home location, medical practice or hospital location,marital status, employment, background and lifestyle metrics.

In the embodiments being described, the demographic informationcomprises at least one of age, gender, ethnicity and socio-economicgrouping.

In the embodiments being described, the physical attributes comprise atleast one of physical height and weight.

In the embodiments being described, the fitness and activity informationcomprises at least one of number of steps taken, frequency of exercise,level of physical activity and attitudes to fitness and activity.

In the embodiments being described, the dietary information comprises atleast one of type of food eaten, volume of food eaten, time of dayeaten, types of diets undertaken, food allergies, and attitudes to food.

In the embodiments being described, the medical information comprises atleast one of previous medical history, medical conditions recorded,blood test results and genetic pre-conditions and risk elements.

In the embodiments being described, the reference information comprisesat least one of a Patient ID number, a Client ID Number, a NationalHealth Service (NHS) Reference Number, Oxford Innovations or AmericanHeart Association health outcomes reference, or any other UniqueIdentifying number, letter or other designation used as a reference. Forexample, any designator familiar to a healthcare professional or otherhealth related organisation may be used.

In addition, a BVI® designation for the subject may also be used. BVI®designation means the BVI® number assigned to the individual, ascalculated using the methods described herein. The BVI® designation maybe encoded or presented in such a way as to include information allowingthe subject to be identified in some embodiments.

Some or all of the metrics above for a plurality of people are stored ina body database in the embodiment being described. In some embodiments,the body database is used to collect aggregated data statistics, whichmay then be stored in a separate database (optionally anonymised).

Data 502, 504, 506 stored in the body database are used to define firstand second empirical formulae 510 for predicting Visceral Fat and TotalBody Fat (internal body composition data) 520 based on external 514 anddemographic 512 information.

The data 502, 504, 506 stored in the body database are used to define athird empirical formula 510, the output of which is the BVI® 520, and isconfigured to give an indication of health risk, and in particular ofobesity and cardio-metabolic risk. As these are correlated to Total BodyFat and Visceral Fat, the BVI® therefore provides a measure of TotalBody Fat and Visceral Fat, i.e. internal body composition data, whilstrequiring only external and demographic data from a subject. The needfor costly, time-consuming and potentially-daunting MRI scans or thelike to obtain a general health indicator may therefore be reduced oreliminated for the subject by the use of BVI®.

This process 500 is summarised in FIG. 5

In these embodiments, the BVI® is configured to provide an indication ofthe health or fitness of a subject.

In these embodiments, the BVI® is calculated and assessed by combiningdata on the subject with data on other people stored in the bodydatabase so as to (implicitly or explicitly) extract a typical bodycomposition for the subject from the body database, based upon bodyvolume calculations, and then calculating an indication of health riskaccordingly. In some embodiments, predicted Total Body Fat and/orVisceral Fat may be calculated and used as inputs to the BVI® formula.

During extensive, independent scientific and medical evaluation of partbody volume measurements, a variety of possible indices wereinvestigated as suitable candidates for, or components of the BVI®biomarker:

Possible Volume Indexes Volumes (Body Part Volumes)

1. Chest

2. Abdomen

3. Pelvis

4. Upper limbs

5. Lower limbs

6. Neck

Circumferences (Body Length Measurements)

A. Waist

B. Hip

C. Neck (circumference and height *)

D. Arm (mid point)

E. Thigh (mid point)

* Neck Height from the ground

Possible Body Volume Indexes Circumference Indexes

Index=(1+2)/Total Volume

Index=A/B

Index=2/Total Volume

Index=A/height

Index=A/height³ (the superscript indicating that height is squared)

Index=(1+2)/(4+5)

Index=(A+C)/B

Index=2/3

Index=(A+C)/(B+E)

Index=Total Volume/height

Index=Tolal Volume/height²

Index=C/B

Index=Total Volume/height³

Index=C/B+E

Index=(1+2+6)/Total Volume

Index=1/(B/height)

Index=(2+6)/(3+5)

Index=1/(B/height²)

Index=(2/Total Volume)/height

Index=(2/Total Volume)/height²

Index=(2/Total Volume)/height³

Index=2/height

Index=2/height²

Index=2/height³

Medical data from over 7,800 patients who had also undertaken a 3D scanin a body scanner 2 was analysed against the prospective 15 indices toestablish which was the most appropriate and significant one for anassessment of risk. Regressional analysis allowed suitable candidateindices for BVI® to be identified.

Following completion of that appraisal, it was established that twoeffective and appropriate measures of risk using part volumes were:

-   -   1. Abdominal Volume as a proportion of Total Body Volume; and    -   2. Abdominal Volume and Leg Volume as a proportion of Total Body        Volume.

External measurements (length and volume measurements) in conjunctionwith full-body MRI scanner data and demographic information for the samepeople was subsequently used to validate the determined indices. Thisfurther validation augmented and supplemented the validation of volumesto create a ‘synthesis’ and fusion of two (or more) distinct datasets,allowing linear, volumetric and MRI data to become used and validatedfor the first time. In the embodiment being described, the differentdatasets comprise data on the same subjects. Linear, volumetric, MRIdata and reference to existing known biomarkers such as Cholesterol andGlucose derived from the subject blood results were used and validatedin the creation of a BVI® biomarker as a predictive indicator of healthrisk.

The third empirical formula was adapted to include modificationsaccording to demographic information such as age, ethnicity and genderin addition to the external body data.

Over 15 different indices of body volume parameters were reviewedagainst known indicators of obesity and cardio-metabolic risk. In oneembodiment, a combination of total body volume and volume of the abdomenwas selected as providing the best combination of measurements for theenrichment of current cardio-metabolic risk prediction methods, and isused for the BVI® calculation, optionally with height, weight, and/orgender also used.

In another embodiment, the following equation is used to calculate BVI®:

BVI=u−v*(abdominal_volume_litres/(height_metres*height_metres))−w*age_years−x*gender+y*height_metres−z*waist_girth_cms

Coefficients u to z in the equation above are constants derivedempirically from data in the body database.

The skilled person working in the field will appreciate that averagebody shapes vary for different populations throughout the world, forexample when comparing Asian populations to European populations or toAfrican populations, or even comparing north-eastern European tosouthern European populations. The coefficients (u to z, or equivalentfor other embodiments) are therefore adjusted based on data for thepopulation of interest in various embodiments, so as to provide a moreaccurate health indicator, accounting for genetic and/or culturalvariation in body shape.

In a similar way, this fusion of internal and external data in the bodydatabase was used to generate the first and second empirical formulae,such that Total Body Fat and Visceral Fat predictions can also be madefrom just external data (e.g. one or more of height, weight, body partvolumes and/or lengths, etc.) and demographic data (e.g. one or more ofage, gender, ethnicity, activity level, etc.). The fusion of internalbody composition data (e.g. MRI and/or Cadaver data) and externallyderived 3D body part data (lengths and volumes) to form the formulaefacilitates this prediction.

The skilled person will appreciate that the number of differentparameters of the BVI®, Total Body Fat and/or Visceral Fat, or thelikes, determination approaches may be increased to increase accuracy,but that this put more of a burden on the subject in terms of supplyingrelevant information. A trade-off between accuracy and simplicity of usecan therefore be struck according to intended use. The skilled personwill appreciate that, for BVI® to be a useful alternative to BMI, it hasto be similarly available and deployable as a quick, efficient and validtool.

This method 300 is summarised in FIG. 3. Firstly, data are obtained 302including some or all of the information and measurements discussedabove and optionally additional metrics known to provide healthindications (for example, visceral fat content as obtained from MRIdata), as well as demographic data of the individuals whose data areincluded. Then, relationships between the various metrics areinvestigated so as to find correlations 304.

Based on these relationships, the empirical formulae which provide aprediction of internal body composition from external data (such as 3Dimages and a 3D model formed therefrom) and demographic data are thendetermined 306. Multiple external and demographic metrics are used withthe intention of overcoming some of the drawbacks of prior art metricssuch as Body Mass Index, which does not take into account body shape atall, nor whether mass is a result of muscle or fat.

The measure of internal body composition can be or comprise a directmeasure such as Total Body Fat or Visceral Fat, and/or may be orcomprise an indirect measure including multiple factors to provide ahealth indication, such as BVI®.

In the embodiments being described, the BVI® number provides anindication of the scale of the health risk or fitness of a person, byreference to a series of ranges.

In one embodiment, the BFI® number is defined as being from 0-20, withfour numerical sub-ranges (0-<5, 5-<10, 10-<15, and 15-20). The skilledperson will appreciate that the total available range could besub-divided into more or fewer sub-ranges for comparison, and/or thatthe total range of BVI® may be different, including the option of beingunlimited, in other embodiments.

The principle of BVI® is to establish a new Health Indicator based uponweight distribution (as opposed to total weight and total height only);delivered through the measurement of part-volume of the human body froma 3D scan or equivalent.

Summarised below is the process undertaken in the development of thebody volume technology in order to establish a preferred BVI® “number”and an appropriate series of ranges for that number:

-   -   STAGE 1—Desk research and analysis of MRI full-body data;    -   STAGE 1b—Validation and confirmation of accuracy levels of BVI®        software for part volume measurement, including validation for        total body volume against BodPod®;    -   STAGE 2—Desk research and analysis of cadaver data;    -   STAGE 2b—Validation and confirmation of accuracy levels of BVI®        software for body composition;    -   STAGE 3—Trials of body volume 3D software with MRI data using        the same subjects;    -   STAGE 3b—Validation and confirmation of accuracy levels of BVI®        software for body composition;    -   STAGE 4—Overall review and analysis of data outputs from Stages        1-3;    -   STAGE 5—Trials of linear 3D software with manual measurements        using same subjects; and    -   STAGE 6—Review of data and devising of algorithms for the BVI®        number and ranges.

Having reviewed the 15 possible indices discussed above, it was decidedto adopt and use abdominal volume as related to total body volume as theprimary basis for the BVI® calculation. Weight distribution was measuredusing the part volume 3D calculations, enhanced and adjusted byreference to cadaver data to include the ratios between weight andvolume of different body parts within each body section.

In view of this, certain definitions and ranges for abdomen volume wereestablished, using the extensive 3D datasets. These ranges were defined(and written in language for the healthcare professional) as being aslisted below in one embodiment. The skilled person will appreciate thatthis is an example only, and that other ranges and definitions may beused.

Abdomen Volume

The BVI® technology allows, for the first time, the measurement of theabdominal region of the body; the area of the body where excess weightis most commonly associated with health risk. Whilst excess abdominalvolume in a subject is visible to the human eye, prior health indicationtechniques cannot extract and remove the abdominal volume from the bodyin practice; other than by cadaver dissection after a patient has passedaway. Extraction of part volumes, including volume of the abdomen, froma 3D model, and use cadaver and MRI data as empirical reference data tointerpolate body composition of the abdomen and other part volumestherefore provides a novel and beneficial approach.

For the purposes of the calculations described herein, the abdominalregion is defined as being broadly measured from the bottom of theribcage to the pelvic bone, and more specifically to the top of thepelvic bone; the iliac crest. This entire area is what is more commonlyknown as the ‘belly’ or the ‘stomach’ which is the part of the bodywhere excess fat deposits, such as visceral fat located around theorgans, can cause health problems and are generally thought to be mostindicative of potential health issues. The exact abdominal volumecalculated as a proportion of total volume may be different according todifferent body shapes of subjects (e.g. hourglass, pear-shaped,apple-shaped), but the software has been designed to capture the area ofan individual that might reasonably be thought of as their ‘belly’. Theimportance of this is that a subject with a ‘pot belly’ will have theentire abdominal volume measured using BVI®, including the area justabove the groin. This area of the body is generally neither practicalnor appropriate to measure manually.

During the image capture process (which may be 3D or 2D Image capture),a patient or client is advised to breathe out and hold their breath forabout 5-6 seconds as the image is taken. The BVI® software will measurethe abdomen as a proportion of the total volume (less head, hands andfeet in the embodiments being described). The head is excluded as thevolume of hair is not a health issue; nor do people who have big feet orlarge hands have a greater or lesser health risk.

The volume of the abdomen is also indicative of amounts of visceral fatdeposited within the body. Visceral fat is known to be relevant tohealth. Visceral fat, located around the major organs, is known to berelevant and a significant indicator to health risk.

Ranges for Abdomen Volume (Same for Both Male and Female) Below 5.00%

If the abdomen volume is below 5%, then this could be indicative of asubject's low total body volume, a specific body shape (e.g.‘hourglass’) or may be reflective of other health issues which requirefurther consultation. It is very unusual for the abdomen volume to beless than 5% of the total weight. Therefore in this case, the Physicianor Healthcare Advisor should give advice to the subject taking otherdata from the BVI® technology and other factors into account.

5.0%-9.9%

Within this range, the subject has a low level of abdomen volume whichis indicative of a healthy body shape and health risk. The Physician orHealthcare Advisor should offer advice to the subject taking other datafrom the BVI® technology and other factors into account if that isdeemed to be necessary.

10.0%-14.9%

Within this range, the subject has an average level of abdomen volumewhich is indicative of a healthy body shape and health risk. ThePhysician or Healthcare Advisor should offer advice to the subjecttaking other data from the BVI® technology and other factors intoaccount if that is deemed to be necessary.

15.0%-19.9%

Within this range, the subject has a relatively high level of abdomenvolume, which is indicative of a less healthy body shape and healthrisk. The Physician or Healthcare Advisor should offer advice to thesubject taking other data from the BVI® technology and other factorsinto account if that is deemed to be necessary.

20%-24.9%

Within this range, the subject has a high level of abdomen volumerelative to total volume, which is a sign of potential health problemsand health risk. The Physician or Healthcare Advisor should offer adviceto the subject taking other data from the BVI® technology and otherfactors into account to provide the subject with appropriate exerciseand diet programs. This will help the subject to reduce their abdominalweight and improve their health.

25.0%-29.9%

Within this range, the subject has a very high level of abdomen volumewhich is indicative of health risk and possible excess visceral fat inthe abdomen. The Physician or Healthcare professional should review allother factors and suggested appropriate remedies and programsappropriate to the needs of the subject to improve their health.

Having defined the ABDOMEN VOLUME the VISCERAL FAT and TOTAL FAT RANGESare now described. These are detailed below for one embodiment:

Total Body Fat Ranges (as Written for a Healthcare Professional) WomenRange Between 5% and 11%

The body fat percentage (BFP) for males and females is the total mass offat divided by total body mass; body fat includes essential body fat andstorage body fat. Essential body fat is necessary to maintain life andreproductive functions. The percentage of essential body fat for womenis greater than that for men, due to the demands of childbearing andother hormonal functions.

This subject has a very low fat content in their body which is good fortheir health, but some fat in the body is essential for healthy living.The healthcare professional could advise the subject to begin a programthat is appropriate for them, if that is required or if the situationchanges.

Range Between 11% and 22%

This subject has a relatively low amount of fat in their body but thismay increase if their lifestyle changes or their dietary requirementsworsen. The subject should keep to the same lifestyle and levels ofexercise that they are currently doing. However, the subject could beadvised to begin a program that may be appropriate for them if that isrequired or if the situation changes.

Range Between 22% and 28%

Body composition constantly changes and comparing ratios over time isonly relevant as a broad indicator of how healthy a subject's weight is.The figure given determines the level of fat, but doesn't indicate theposition of the fat on the body, or its potential implications.

A normal body composition does include some essential fat, but beyond acertain percentage, the subject may be at risk of weight-relateddiseases such as diabetes and heart problems.

By tracking BVI® over time, the subject's progress can be tracked to seeif any improvements they are making to their physical activity and dietare making an impact on their physical condition and weight.

The subject has no need to be concerned or anxious, but they have arelatively high level of total body fat, which could affect their mood.It is important to inform the subject that they should not increasetheir body fat percentage above these levels and offer advice to begin aprogram, appropriate for them, which will help to avoid an increase intheir body fat levels.

Range Between 28% and 38%

This subject has a high body fat content, so it is important todetermine whether the fat is subcutaneous or visceral. A high level ofsubcutaneous fat is not a health risk for the subject, whereas a highlevel of visceral fat means the opposite; hence the importance of weightdistribution measured through part volumes which allows the location offat, as opposed to total fat, to be realised and represented for thefirst time through BVI®.

Tracking a subject's body fat percentage is an accurate measurement oftheir health and fitness, but it is more relevant for health risk tomeasure their visceral fat percentage, so BVI® data can offer guidanceon risk and help with their personal health goals.

The level of the subject's visceral fat can be checked against the BVI®chart ranges. If required, the healthcare professional can advise thesubject to begin a program that is appropriate for them or as and whenthe situation changes, or conversely, a subject may appraise themselvesof their own situation and seek advice or make their own plansaccordingly.

Range Between 38% and 48%

For women, the general body fat range is anywhere between 14% and 31%and at least 10% body fat is required to be healthy. A woman with morethan 32% body fat is considered obese. This subject has a high level ofbody fat so should be advised to take action to reduce this wherepossible.

There could be any number of reasons why this is the case so after anassessment of the subject, a specific program that will be appropriatefor their specific circumstance can be recommended.

Range Over 48%

If the subject has a body fat range in excess of 48%, then this is apotential health risk as the percentage of body fat is likely to includeexcess visceral fat in addition to the essential subcutaneous fat. Anexcess amount of visceral fat is considered to be a potential healthrisk and specific advice should be provided to a subject that has beenassessed as having this amount of total fat.

Men 3-23%

If a man's body fat is less than 3%, his health may be compromisedbecause normal, healthy functioning requires some essential subcutaneousfat. He may become more susceptible to illness or experience chronicfatigue. 3% of body fat is considered to be essential for men as somefat is necessary for normal, healthy functioning.

In men, essential fat is approximately 3% of body weight. Women,however, have a higher percentage of essential fat—about 12%, due toessential fat found in the breasts, pelvis, hips and thighs. Thissex-specific fat is believed to be critical for normal reproductivefunction.

Visceral, or storage fat accumulates beneath the skin, in certainspecific areas inside the body, and in muscles. It also includes thedeep fat that protects internal organs from injury. Men and women havesimilar amounts of storage fat.

The subject does have a low volume of fat but nothing so low to raiseconcerns. The subject could be advised to begin a program that isappropriate for them, if that is required or if the situation changes.

23%-34%

If the subject's percentage body fat goes above a desirable range, theyhave an increased risk of developing heart disease, high blood pressure,gallstones, type 2 diabetes, osteoarthritis, certain cancers and for anearly death. In some cases, the excess fat becomes a mechanical barrierto breathing properly. This condition is called sleep apnea.

BVI® can inform a health professional and the subject where any excessfat is located, which is important. Recent studies have shown that thereis a higher risk associated with carrying extra fat around the waist,rather than the thighs and buttocks, which can be healthy.

It will benefit the subject's health if they can maintain a healthyweight and to keep body fat in check, improving longevity and quality oflife.

Within this range, the subject has no need to be concerned or anxious.The healthcare professional could offer advice to begin a program,appropriate for them, which will help avoid an increase in their bodyfat levels.

34%-40%

Studies show that maintaining a healthy weight compared to heightreduces risk and being obese increases risk. People with excess body fatare more likely to eat a diet high in fat content—with less fruit &vegetables, so they may be missing out on essential nutrients. Thesubject's total body fat percentage does indicate a certain level ofconcern, but the fat type remains the most important factor. Thesubject's visceral fat levels and abdominal volume should be utilised asa better indicator to determine the level of risk and any actionrequired.

If appropriate, the subject could be made aware that this result is acause for concern and if required, advised to begin a program that isappropriate for them or as and when the situation changes.

40%-46%

Within this range, would exist a high propensity and risk for Type IIDiabetes and sufferers of Type II Diabetes should be advised to eathealthily and try to maintain a healthy weight for their height. Abalanced diet with plenty of fruit and vegetables, and the bulk ofstarchy foods, means that the type II diabetic can consume a smallamount of sugar—and foods containing sugar can be included (on a smallscale) in the day to day diet.

For a subject within this range, their total body fat volume isconcerning and will indicate a tendency of additional abdominal volumeand the associations with the volume of visceral fat. The subject'svisceral fat levels should be checked and they should be advised tobegin a program that is appropriate for them and which will help themavoid an increase in their body fat levels.

Over 46%

For men, the general body fat range is anywhere between 6% and 25% andat least 3% body fat is required to be healthy. A man with more than 26%body fat is considered obese. This subject has a high level of body fatso you need to advise them to take action to reduce this where possible.

This total body fat poses a health problem for your client as excessbody fat contributes to an array of medical conditions/diseases. Notmaintaining a healthy weight for their height can greatly increase theirrisk of contracting conditions such as Coronary Heart Disease, Diabetes,some Cancers and other conditions such as Gallstones. The visceral fatindicator of body volume is likewise a representation of the riskfactors involved.

The healthcare professional should provide specific advice to a subjectwithin this range to begin a program that is appropriate for them and toimprove their health.

Finally, having assessed and delivered both indicators and ranges forABDOMEN VOLUME, VISCERAL FAT and TOTAL BODY FAT ranges, the final stagewas establishing a ‘range’ for the BVI® number to correspond to theexisting BMI scale. The skilled person would appreciate that an entirelydifferent scale could be chosen in some embodiments, but that aligningthe scale for BVI® with that for BMI makes the numerical system morefamiliar and easier to understand for users familiar with BMI as anindication of a risk to health.

For the representation of BVI®, it was decided to use a range of between0 and 20, so as to ‘tag on’ to the most commonly used lower-range BMInumbers and also to create a structure of 5-digit ranges; familiar toanyone who is using, has used, or is familiar with the BMI number andits most commonly used ranges of 18-35 in a two-digit format.

Visceral Fat

These are detailed below, with ranges reviewed and validated as beingscientifically representative by renowned experts in the field. Therepresentation of the values in pounds is indicative of what is deemedappropriate for the US population, but likewise, may also be appropriateto be represented in litres, as a percentage or other known value, asappropriate to the accepted norms and measurement values as used in anygiven population.

Women Range Between 0.22 and 3.3 Pounds (0.5 kg to 7.3 kg)

Within this range, this subject has a very low visceral fat content.Advice should include avoiding overfeeding, particularly if the subjecthas a low-activity lifestyle. A healthcare professional could advise thesubject to begin a program that may be appropriate for them if that isrequired or if the situation changes.

Range Between 3.3 and 6.6 Pounds (7.3 kg to 14.5 kg)

Fat is a living part of the body; releasing chemicals, toxins andhormones into the blood stream which can affect many bodily functions.This subject has a relatively low amount of visceral fat but could beadvised to begin a program that may be appropriate for them if there areother factors that may indicate a need to do so.

Range Between 6.6 and 11.0 Pounds (14.5 kg to 24.2 kg)

Visceral fat can affect mood of human beings by increasing production ofCortical (stress hormone) which reduces levels of endorphins. Thissubject has a relatively high level of visceral fat and it is importantthat this should not increase. The subject could be advised to begin aprogram appropriate for them.

Range Between 11.0 and 15.5 Pounds (24.2 kg to 34.1 kg)

There is evidence that visceral fat causes inflammation in the colon andthe artery walls and is a major cause of heart disease, diabetes andsome types of cancer. This subject has a high level of visceral fat andshould take some action. The subject could be advised to begin a programappropriate for them.

Range Between 15.5 and 20.0 Pounds (34.1 kg to 44 kg)

Subjects within this range have a very high level of visceral fat intheir body and therefore must start to move often and adopt a healthylifestyle to reduce this. A healthcare professional should advise theirclient to begin a program appropriate for them.

Men Range Between 0.22 and 5.5 Pounds (0.5 kg to 12.1 kg)

There is evidence that visceral fat burns away uniformly with exercise.This subject has a very low visceral fat content and presents withlittle risk. The subject could be advised to begin a program appropriatefor them if that is required or if the situation changes.

Range Between 5.5 and 10 Pounds (12.1 kg to 22 kg)

Any subject within this range has a relatively high level of visceralfat and needs to take evasive steps to manage their lifestyle and thecauses of visceral fat. It is important to note that appearance isunrelated to the levels of visceral fat. This is commonly known as a‘TOFI’ body type—thin on the outside, but fat on the inside. Ahealthcare professional should advise the subject to begin a fitness andexercise program appropriate for them to help manage this situation andreduce their visceral fat volume.

Range Between 10 and 13.25 Pounds (22 kg to 29.2 kg)

The liver metabolises visceral fat and then releases it into thebloodstream as cholesterol. Low-Density Lipoprotein (LDL), commonlyknown as ‘bad cholesterol’, builds up into a plaque that blocks thearteries. An increase in fat carried on the body, causes an increase inharmful toxins which are released into the bloodstream and stored in thebody. Any man within this range is carrying a significant amount ofvisceral fat and the healthcare professional should advise the subjectto begin a program appropriate for them to help manage this situationand reduce their visceral fat volume.

Range Between 13.25 and 20.00 Pounds (29.2 kg to 44 kg)

It is not necessary to be overweight to have a large amount of visceralfat. There are case histories of underweight individuals who have up to15 pounds of hidden visceral fat. This is commonly known as a ‘TOFI’body type—thin on the outside, but fat on the inside. A subject in thisrange is carrying a significant amount of visceral fat and should beadvised to begin a program appropriate for them to help manage thissituation and reduce their visceral fat volume.

Range Between 20.00 and 28.5 Pounds (44 kg to 62.7 kg)

This range represents a very high level of visceral fat and should beaddressed to protect long-term health and wellbeing. The subject shouldbe advised to begin a program appropriate for them to help manage thissituation and reduce their visceral fat volume.

The explanation for the BVI® number is included in this text with theset ranges within which a specific designated number for any givensubject may lie. The empirical formula, combining height, weight,gender; total body volume and volume of the abdomen as chosen for theBVI® calculation of the embodiment being described, is scaled to providevalues within this range as appropriate.

Ranges for the BVI® Indicator Number

(As described for a healthcare professional representing or being askedto advise a subject on their health)

The Body Volume Indicator (BVI®) has been developed over years ofresearch by Select Research and collaborators. The BVI® of theembodiment being described derives total body volume, less the head,hands, and feet (for example from two digital images, or from a 3D scanif available) that then is divided into seven body part volume sections;Chest, Abdomen, Pelvis, Left Arm, Right Arm, Left Leg, Right Leg.

The empirical formula combining height, weight, gender; total bodyvolume and volume of the abdomen was selected to represent BVI®following an appraisal and evaluation of 15 part volume equations. Forthe BVI® index, calculation is scaled to provide values within thisrange as appropriate.

Ranges BVI—0-4.9

A subject within this range has a very low BVI® number may put them atlow risk of developing cardio-metabolic disease. The abdominal volume inproportion to the total volume is adequate. However, a healthcareprovider should still review other risk factors and provide advice onhow to continue with a healthy diet and lifestyle.

BVI—5.0-9.9

The subject's BVI® number may indicate that they are at low to mediumrisk for cardio-metabolic disease, as a result of their abdominal volumebeing higher in proportion to their overall total body volume. However ahealthcare provider should still review other risk factors and provideadvice on how to continue with a healthy diet and lifestyle.

BVI—10.0-14.9

The subject's BVI® number is indicative of them being at moderate riskfor developing cardio-metabolic disease, as their abdominal volume ishigh in proportion to their total body volume. However a healthcareprovider should still review other risk factors and provide advice onhow to continue with a healthy diet and lifestyle.

BVI—15.0-19.9

The subject's BVI® number may be indicative of a high risk of developingcardio-metabolic disease, as their abdominal volume is high as aproportion of their total body volume. However a healthcare providershould still review other risk factors and provide advice on how tocontinue with a healthy diet and lifestyle.

In various embodiments, the Body Volume Indicator is collected anddisplayed on a smartphone by the use of two digital images through theBVI® Pro iOS app; specifically designed for healthcare professionals.The BVI® Pro, which includes the BVI biomarker number was launched onMay 1, 2017. In addition, BVI® has been approved as a ‘medical device’by the Medical Healthcare Evaluation Authority (MHRA), confirmed asbeing classified ‘general wellness’ product for the Food and DrugAdministration (FDA) and has been CE Marked across Europe.

Since the launch in May 2017, the BVI® Pro has been used for themeasurement of subjects in over 67 countries across the world by users.The launch of the BVI® Image Application Programming Interface (API) inApril 2018, which includes the BVI® algorithms as described above, isintended to further enhance the opportunities for integration of theBVI® biomarker in healthcare. The increased use of BVI® across the worldby healthcare professionals, health and wellness companies and byindividual subjects can only assist us in better understanding,monitoring, evaluating and improving the health of our nations and theircitizens.

What is claimed is:
 1. A system for calculating a health indicator of anindividual, comprising: (a) a camera for capturing at least two uniqueimages of the individual; (b) a data collector for capturingmeasurements from the images; and (c) a calculator for: calculating atleast one body volume using the measurements captured by the datacollector, so as to provide the health indicator, the health indicatorcomprising a prediction of internal body composition.
 2. The system ofclaim 1 wherein the system further comprises a body composition databasecomprising internal body composition data for other individuals, andwherein the calculator is arranged to provide the prediction of internalbody composition for the individual captured in the images by inferencebased on the body composition database data.
 3. The system of claim 1wherein the calculator calculates multiple body volumes of body parts ofthe individual.
 4. The system of claim 1 further comprising a processorfor converting the captured images into a 3D model of the individual. 5.The system of claim 1 wherein the data collector further measures atleast one of: a girth measurement, a length measurement, and a surfacearea measurement.
 6. The system of claim 1 further comprises: (d) afirst database comprising measurements obtained based on the images. 7.The system of claim 6 wherein the first database further comprisessupplemental health information for the individual provided by at leastone of a third party and the individual.
 8. The system of claim 1wherein the calculator is a cloud-based analysis system.
 9. The systemof claim 1 wherein the calculator measures a first body volume of afirst body part and compares it to a second body volume from a secondbody part.
 10. The system of claim 6 further comprises (e) a seconddatabase comprising at least one of measurements and images from a knownpopulation, (f) means to compare values in the first database to valuesin the second database.
 11. The system of claim 10 wherein the data fromthe first database is compared to a subset of data from the seconddatabase selected based on at least one of the gender, age, or ethnicityof the individual.
 12. The system of claim 1 further comprises: (g) anartificial intelligence module coupled to the calculator for altering animportance factor associated with the measurements in calculating thehealth indicator.
 13. The system of claim 1 wherein the health indicatorcomprises a prediction of body composition of the individual, theprediction including at least one of total body fat, visceral fat, liverfat, muscle, adipose tissue, fat free mass, subcutaneous fat and bonemass.
 14. The system of claim 1 wherein a calculated body volume istotal body volume, and wherein the volume of the individual's head isexcluded in the calculation of total body volume.
 15. A health indicatorsystem for providing a calculated value to an individual based on ahealth risk of the individual, the system comprising: (a) a scanner forcapturing image data of the individual; (b) a calculator for calculatinga body volume from collected measurements from the image data; whereinthe calculator details a first region of the body volume and compares itto a second region of the body volume; (c) a first database for storingthe collected measurements and calculated body volumes for theindividual; (d) a second database for storing data from third partiesincluding measured values for visceral fat and/or total body fat; and(e) comparison means for identifying values in the second database thatcorrespond to the collected measurements, so as to provide a healthindicator.
 16. The system of claim 15 further comprises: (g) anartificial intelligence module coupled to the calculator for altering animportance factor associated with the measurements from the 3D model incalculating the health indicator.
 17. The system of claim 15 wherein thehealth indicator comprises a prediction of body composition of theindividual, the prediction including at least one of total body fat,visceral fat, liver fat, muscle, adipose tissue, fat free mass,subcutaneous fat and bone mass.
 18. The system of claim 15 furthercomprises: a processor for converting the captured images into a 3Dmodel of the individual.